Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones.

Urolithiasis Clinical Trial

Official title:

Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04153461
• Other study ID #: MiniPNL
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: November 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research .

The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 210
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient 18 years or older.

2. ASA I or II

3. Renal stones = 2 cm

4. Lower calyceal stone = 1 cm

5. Failure of other modalities of treatment as ESWL and RIRS.

Exclusion Criteria:

1. S.creatinine > 2mg/dl.

2. Patients with active UTI.

3. Patients on anticoagulant.

4. Age <18 years.

5. Ureteral obstruction preventing the insertion of a ureteral stent.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• MINIPERC
• Nephrolithiasis
• NEPHROLITHOTOMY
• PCNL
• PNL
• Stone;Renal
• Urolithiasis

Intervention

Procedure:
• MINI-PERCUTANEOUS NEPHROLITHOTOMY
MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
• STANDARD PERCUTANEOUS NEPHROLITHOTOMY
PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION

Locations

Country	Name	City	State
Egypt	Urology and Nephrology Center	Mansoura	Aldakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of stone free rate (SFR)	defined as less than 4mm by non contrast computed tomography	2 years
Secondary	assessment of haemoglobin loss	measured by haemoglobin change pre and postoperative (measured by grams/ deciliter)	2 years
Secondary	assessment of pain	measured by visual analogue scale	2 years
Secondary	assessment of renal function	measured by serum creatinine measured by Milligram/ deciliter	2 years
Secondary	assessment of patient satisfaction	measured by freiburg index of patient satisfaction	2 years